Biodenta bone level tapered dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures.

Device Description

The Biodenta Dental Implant System - Bone Level Tapered is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants and related surgical instruments. The Bone Level Tapered implants use the same platforms and abutment connections like the Bone Level implants (K111003), and therefore the abutments and prosthetic parts of the Bone Level implants are used with the Bone Level Tapered implants.

The System includes dental implants with the following dimensions:

Diameter 3.5 mm Implants with Length of: 8, 10, 12, and 14 mm; Platform B1
Diameter 4.1 mm Implants with Length of: 8, 10, 12, and 14 mm; Platform B2
Diameter 4.8 mm Implants with Length of: 8, 10, 12, and 14 mm; Platform B2
Diameter 6.0 mm Implants with Length of: 8, 10, and 12 mm; Platform B2

AI/ML Overview

The provided document is a 510(k) summary for the Biodenta Dental Implant System - Bone Level Tapered. It details the device's indications for use, description, and a comparison to predicate devices, focusing on demonstrating substantial equivalence.

However, the document does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML algorithm or a human-in-the-loop study. The "Non-clinical Testing Data" section only mentions fatigue testing according to FDA guidance and ISO 14801 for mechanical strength. This is a physical device (dental implant), not a software or AI/ML device that would typically have acceptance criteria presented in the requested format.

Therefore, I cannot provide the requested table and study details. The information requested (sample sizes for test and training sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth) is only relevant for studies validating AI/ML-based medical devices, which is not the subject of this 510(k) submission.

Summary

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Premarket Notification / 510(k) Submission Biodenta Dental Implant System - Bone Level Tapered 5 - 510(k) Summary

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Image /page/0/Picture/2 description: The image shows the word "biodenta" in black font with a registered trademark symbol. Above the word is a curved design with three lines. The font is simple and easy to read. The logo is likely for a dental product or service.

0 510(k) Summary

Owner's name:	Biodenta Swiss AG
Address:	Tramstrasse 16
	9442 Berneck
	Switzerland
Phone:	+41 71 747 11 11
Fax number:	+ 41 71 747 11 12
Contact person:	Mr. David Eiler, Regulatory Manager
Date summary prepared:	Feb. 04, 2013
Trade / proprietary name:	Biodenta Dental Implant System - Bone Level Tapered
Common name:	Endosseous dental implant
Device classification name:	implant, endosseous, root-form
Product code:	DZE
Regulation number:	21 CFR 872.3640

Legally marketed device to which equivalence is claimed (predicate device):

1. Company:	Biodenta Swiss AG
Device name:	Biodenta Dental Implant System - Bone Level
510(k) number:	K111003
2. Company:	Keystone Dental
Device name:	Genesis Implant System
510(k) number:	K101545

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Premarket Notification / 510(k) Submission Biodenta Dental Implant System - Bone Level Tapered 5 - 510(k) Summary

Image /page/1/Picture/2 description: The image shows the logo for "biodenta". The word "biodenta" is written in a bold, sans-serif font. Above the word "biodenta" is a graphic of three curved lines. To the right of the word "biodenta" is a circled R, which is the registered trademark symbol.

Indications for Use:

Device Description:

The System includes dental implants with the following dimensions:

Diameter 3.5 mm Implants with Length of: 8, 10, 12, and 14 mm; Platform B1
Diameter 4.1 mm Implants with Length of: 8, 10, 12, and 14 mm; Platform B2
Diameter 4.8 mm Implants with Length of: 8, 10, 12, and 14 mm; Platform B2
Diameter 6.0 mm Implants with Length of: 8, 10, and 12 mm; Platform B2

Non-clinical Testing Data:

Fatigue testing was conducted according to FDA Guide: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments -Guidance for Industry and FDA Staff and ISO 14801 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants. The worst case scenario for the Biodenta Dental Implant System - Bone Level Tapered implants and abutments was tested. These results show that Biodenta Dental Implant System - Bone Level Tapered have sufficient mechanical strength for their intended clinical application.

Equivalence to marketed device:

Biodenta Swiss AG demonstrated that, for the purposes of FDA's regulation of medical devices, the Biodenta Dental Implant System - Bone Level Tapered is substantially equivalent to the predicate devices in intended use, material composition, fundamental scientific technology, principles of operation, and basic design.

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Premarket Notification / 510(k) Submission Biodenta Dental Implant System - Bone Level Tapered 5 - 510(k) Summary

Image /page/2/Picture/2 description: The image shows the logo for "biodenta". The logo consists of the word "biodenta" in a bold, sans-serif font, with a stylized graphic above it. The graphic appears to be three curved lines stacked on top of each other, resembling a stylized leaf or wave. A registered trademark symbol is present to the right of the word "biodenta".

Summary Substantial Equivalence Comparison to predicate devices:

	Subject Device		Predicate Devices
Device Name	Biodenta Dental ImplantSystem - Bone LevelTapered	Biodenta Dental ImplantSystem - Bone Level(K111003)	Genesis Implant System (K101545)
	Intended Use
Intended use	Biodenta bone level tapereddental implants are intendedfor surgical placement inmandibles or maxillae tosupport single or multipletooth restorations or terminalor intermediate abutmentsupport for fixed orremovable bridgework and toretain overdentures.	Biodenta bone level dentalimplants are intended forsurgical placement inmandibles or maxillae tosupport single or multipletooth restorations orterminal or intermediateabutment support for fixedor removable bridgeworkand to retain overdentures.	The Genesis Implant System isintended for use in single-stage ortwo-stage surgical procedures in alltypes of bone in partially or fullyedentulous mandibles and maxillae.The Genesis Implant Systemsupports single or multiple-unitrestorations to re-establish patientchewing function and esthetics.Genesis implants are intended forplacement following natural toothloss or for immediate placement intoan extraction socket. Immediatefunction may be achieved whengood primary stability is establishedand appropriate occlusal loading isapplied.
Basic Design
Implant Type	threaded, root form, bonelevel implant	threaded, root form, bonelevel implant	threaded, root form,bone level implant
Implant Shape	Tapered	Straight	Tapered(+ straight types)
Implants Diameter(& Length)	3.5 mm (8 - 14 mm)4.1 mm (8 - 14 mm)4.8 mm (8 - 14 mm)6.0 mm (8 - 12 mm)	3.5 mm (8 - 14 mm)4.1 mm (8 - 14 mm)4.8 mm (8 - 14 mm)	Tapered Implants:3.8 mm (8.5 - 18 mm)4.5 mm (8.5 - 18 mm)5.5 mm (8.5 - 16 mm)6.5 mm (8.5 - 13 mm)Straight Implants:3.8 mm (8.5 - 18 mm)4.5 mm (8.5 - 18 mm)
Implant to Abut.Connection	Internal Hexagon	Internal Hexagon	Internal 6 lobe
Material	Titanium Grade 4	Titanium Grade 4	Titanium Grade 4
SurfaceTreatment	Spark Anodization(uses same surfacemodification as K111003)	Spark Anodization	Double-acit-etching &Spark Anodization
Abutment System	Angled and Straight(uses same abutments asK111003)	Angled and Straight	Angled and Straight
Abutment Angle	0°, 15°	0°, 15°	0°, 15°
Sterilization(Implants)	Delivered Sterile GammaIrradiation	Delivered Sterile GammaIrradiation	Delivered SterileGamma Irradiation

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 19, 2013

Mr. David Eiler Regulatory Manager Biodenta Swiss AG Tramstrasse 16 Berneck, St. Gallen Switzerland 9442

Re: K123415

Trade/Device Name: Biodenta Dental Implant System - Bone Level Tapered Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: February 14, 2013 Received: February 19, 2013

Dear Mr. Eiler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/4/Picture/7 description: The image shows the text "Kwame O. Ulmer for". The text "Kwame O. Ulmer" is in a larger, bolder font than the word "for". The letters "O.U." are stylized with a geometric pattern.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification / 510(k) Submission Biodenta Dental Implant System - Bone Level Tapered 4 - Indications for Use Statement

Image /page/5/Picture/2 description: The image shows the word "biodenta" in a bold, sans-serif font. Above the word is a graphic element that looks like three curved lines stacked on top of each other. The lines are textured, giving the impression of a natural or organic material. To the right of the word "biodenta" is the registered trademark symbol, a capital R inside a circle.

Indications for Use

× 23415 510(k) Number (if known):

Device Name: Biodenta Dental Implant System - Bone Level Tapered

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S. Runner -S 2013:03.14 07:55:10 -04'00'

Division Sign-Off) (Division Bign-Off)
Division of Anesthesiology, General Hospital Division of Antrol, Dental Devices

12341 510(k) Number;

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Revision ੱ ਹੋ Section ેને Section page 2 of 4.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.